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Completed

NCT Number: NCT02667795

Improving Physical Fitness Prior to Colorectal Surgery: A Pilot Study

It is generally accepted that physically fit patients cope much better with the stress of surgery and recover faster. Consequently several research studies have tried to increase people's level of fitness before they have surgery. These previous research studies have usually required patients to carry out intense, structured exercise programmes that involve going to a gym. However such programmes are not 'user friendly' especially if people are not used to taking a lot of exercise. In this pilot study we want to test the feasibility of a home based programme that tries to increase patients' level of fitness by gradually increasing the number of steps they walk every day.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scarborough General Hospital

Scarborough, Yorkshire, United Kingdom

About this study

Participants will be randomised into one of two groups. One group of participants will be asked to increase their level of activity by gradually walking further (the exercise group) and the other group will carry on with their usual level of activity (the usual activity group) .

Assessments People in both groups will have an assessment on 3 occasions: when they join the study, just before surgery and 3 months after surgery.

This assessment involves:

Walking for 6 minutes up and down a corridor to see how far they can walk. Asking them for some information about their medical history Completing three questionnaires about how they are feeling and their quality of life.

People who are randomised to the exercise group will be advised about how many steps to take based on how they did in the initial walking assessment. The number of days or weeks they will be asked to take a daily walk will depend on how much time there is between them joining the study and the date of their surgery. We think this will be about 2 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Requiring elective resectional bowel surgery
  • Gives consent to participate in the study

Exclusion criteria

  • Younger than 18 years of age.
  • A history of unstable angina/unstable coronary artery disease or a heart attack in the previous month.
  • Any heart related disease including but not limited to aortic stenosis, pericarditis or any thromboembolic disease.
  • Severe Infections and fever.
  • Uncontrolled metabolic diseases.
  • Resting heart rate of more than 120 BPM.
  • Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg.
  • Recent cerebrovascular accident.
  • Pregnancy
  • Pre-existing severe physical disability.
  • Unwilling to allow their GP to be informed of their participation in the study.
  • Not able or unwilling to consent to take part in the study

Treatment and study plan

Monitored walking based exercise

Other

Monitored walking based exercise

Primary outcomes

  1. Change in fitness as assessed by Six Minute Walk Test

    Time frame: Will be done at recruitment, prior to surgery and 3 months post operatively

    Fitness assessment

Secondary outcomes

  1. The EQ-5D

    Time frame: Will be done at recruitment, prior to surgery and 3 months post operatively

    Quality of life assessment

  2. EORTC QLC-C30

    Time frame: Will be done at recruitment, prior to surgery and 3 months post operatively

    Quality of life assessment

Sponsors and collaborators

Lead sponsor

York Teaching Hospitals NHS Foundation Trust

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 29, 2016
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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